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Interactive Effects of Sodium and Potassium on Vascular Health in Older Adults

11. juni 2026 opdateret af: Andrea Lobene, Florida State University

Exploring the Interactive Effects of Sodium and Potassium Intake on Vascular Health in Older Adults

The goal of this clinical trial is to determine if a high potassium intake can counteract the harmful effects of excess sodium on endothelial function in older adults with no history of cardiometabolic disease. The main questions it aims to answer are:

  1. Can a high potassium intake attenuate dietary sodium-induced endothelial dysfunction in older adults.
  2. Do changes in endothelial function in response to alterations in sodium and potassium intake differ by sex.

Participants will participants will consume three controlled diets for 10 days each with a minimum 14-day washout between interventions. The order in which participants consume the diets will be randomized. The study diets will vary in sodium and potassium content. Measures of cardiovascular health (blood pressure, arterial stiffness, endothelial function) will be assessed at the end of each diet.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cardiovascular health declines with age, especially in postmenopausal females. High sodium diets are a major contributor to cardiovascular disease. Unfortunately, reducing sodium intake can be challenging. It is known that increasing potassium intake can improve cardiovascular disease risk factors in young adults, even if sodium intake remains high. The investigators are hoping to show that potassium can improve cardiovascular health in the context of a high sodium diets in older adults. In this study, participants will consume three 10-day controlled diets in a randomized order. The study diets will include: 1) a low sodium (2,000 mg/day)/low potassium (2,000 mg/day) diet; 2) a high sodium (4,700 mg/day)/usual potassium diet; and 3) a high sodium/high potassium (4,700 mg/day). All food will be provided to participants during these periods, and participants will be instructed not to consume any outside food or beverages. Dietary interventions will be separated by a minimum two-week washout period. Measurements of cardiovascular health will be collected at the end of each diet.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: FSU Ann's College
  • Telefonnummer: 850-644-6685

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Florida
      • Tallahassee, Florida, Forenede Stater, 32306
        • Rekruttering
        • Florida State University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Adults ages 55-75 years
  • At least one-year post-menopause (females)
  • Willing and able to attend laboratory visits

Exclusion Criteria:

  • BMI ≥35 kg/m2
  • Seated blood pressure >135/85 mmHg
  • Current diagnosis or history of cardiovascular disease, diabetes, renal disease, cancer, or major cardiovascular event (e.g. heart attack or stroke)
  • Taking exogenous hormones or hormone replacement therapy
  • Following a vegan or gluten free diet
  • Significant weight loss (>10% of body weight) in the last 6 months, or actively trying to lose weight
  • Current or recent use of a diuretic (within the past 6 months) (e.g. spironolactone, eplerenone)
  • Current or recent use of a potassium binding medication (within the past 6 months)
  • Current use of blood pressure lowering medications (e.g. ACE inhibitors, calcium channel blockers, diuretics, vasodilators, beta blockers, AngII receptor blockers)
  • Current or recent use of the medication trimethoprim
  • Elevated blood lipids (LDL cholesterol ≥190 mg/dL)
  • Elevated serum potassium level (>5.1 mmol/L)
  • Elevated BUN (>22 mg/dL)
  • Elevated creatinine (>1.2 mg/dL)
  • Low eGFR (<90 mL/min/1.73 m²)
  • Current or recent use of tobacco, nicotine, or illicit drugs
  • Radical hysterectomy or oophorectomy (females)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: low Na/low K, high Na/low K, high Na/high K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets.
Andet: low sodium/low potassium diet
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
Andet: high sodium/low potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
Andet: high sodium/high potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
Eksperimentel: low Na/low K, high Na/high K, high Na/low K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets.
Andet: low sodium/low potassium diet
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
Andet: high sodium/low potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
Andet: high sodium/high potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
Eksperimentel: high Na/high K, low Na/low K, high Na/low K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets.
Andet: low sodium/low potassium diet
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
Andet: high sodium/low potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
Andet: high sodium/high potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
Eksperimentel: high Na/high K, high Na/low K, low Na/low K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets.
Andet: low sodium/low potassium diet
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
Andet: high sodium/low potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
Andet: high sodium/high potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
Eksperimentel: high Na/low K, low Na/low K, high Na/high K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets.
Andet: low sodium/low potassium diet
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
Andet: high sodium/low potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
Andet: high sodium/high potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
Eksperimentel: high Na/low K, high Na/high K, low Na/low K
Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets.
Andet: low sodium/low potassium diet
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
Andet: high sodium/low potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
Andet: high sodium/high potassium diet
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endothelial function
Tidsramme: "Day 11" after each of the three 10-day dietary interventions
Brachial artery flow-mediated dilation as measured in % dilation
"Day 11" after each of the three 10-day dietary interventions
Blood pressure
Tidsramme: "Day 11" after each of the three 10-day dietary interventions
24-hour ambulatory blood pressure
"Day 11" after each of the three 10-day dietary interventions
Arterial stiffness
Tidsramme: "Day 11" after each of the three 10-day dietary interventions
Carotid-femoral pulse wave velocity
"Day 11" after each of the three 10-day dietary interventions

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Florida State University

Samarbejdspartnere

University of Florida

Efterforskere

  • Ledende efterforsker: Andrea Lobene, Florida State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. marts 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STUDY00006676
  • UF-FSU CTSA Career Development (Andet bevillings-/finansieringsnummer: UF-FSU Clinical and Translational Science Award)

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Kliniske forsøg med Sunde ældre voksne

Kliniske forsøg med low sodium/low potassium diet

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